Status:
ENROLLING_BY_INVITATION
Laparoscopic Isthmocele Repair
Lead Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Conditions:
Isthmocele
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures. Patients were randomized to un...
Detailed Description
The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesar...
Eligibility Criteria
Inclusion
- The study will include women aged 18-45 years who present with symptomatic isthmocele.
- Participants must have a residual myometrial thickness of less than 2.5 mm.
- Participants must desire future fertility.
Exclusion
- Age below 18 or above 45 years
- Atypical endometrial cells or cervical dysplasia on cytology
- Asymptomatic isthmocele
- Candidacy for hysteroscopic surgery
- Cervical or pelvic infections
- Cervical dilation of 4 cm or more (emergency surgery)
- Conditions impairing tissue healing, such as:
- Type 1 or Type 2 diabetes mellitus
- Hematologic disorders associated with bleeding diathesis
- Contraindications for spinal or general anesthesia
- Continuous use of oral contraceptives (OCPs) or GnRH agonists that affect menstrual cycles
- Hydrosalpinx communicating with the uterine cavity
- Intrauterine device (IUD) in place
- Known connective tissue disorders
- Menstrual irregularities:
- Cycles longer than 35 days
- Cycle variations of 2 weeks or more
- Ongoing pregnancy
- Presence of structural abnormalities such as:
- Uterine or cervical polyps
- Submucosal fibroids
- Other similar conditions
- Residual myometrial thickness \> 2.5 mm
- Retained placental tissue
- Suspected malignancies
- Uterine anomalies
- Immunosuppressive diseases
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06918275
Start Date
May 30 2025
End Date
March 15 2026
Last Update
July 17 2025
Active Locations (1)
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1
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, Turkey (Türkiye), 34480